OP0295-HPR THE EFFECT OF GROUP-BASED COGNITIVE BEHAVIOURAL THERAPY FOR INSOMNIA IN PATIENTS WITH RHEUMATOID ARTHRITIS: A RANDOMISED CONTROLLED TRIAL
Authors: K. M. Latocha, K. Løppenthin, M. Østergaard, P. Jennum, M. L. Hetland, H. Røgind, T. Lundbak, J. Midtgaard, R. Christensen, B. A. Esbensen
Journal: Annals of the Rheumatic Diseases (2022)

Background Insomnia is highly prevalent in patients with rheumatoid arthritis (RA) and may exacerbate symptoms and burdens, such as fatigue, depressive symptoms, and pain 1 . Cognitive behavioural therapy for insomnia (CBT-I) has been shown to produce positive effects on sleep in other clinical populations 2,3 . However, CBT-I has not previously been investigated in patients with RA. Objectives The primary objective was to compare the effect of nurse-led group-based CBT-I to usual care on sleep efficiency, measured by polysomnography (PSG) immediately after the intervention (i.e. seven weeks after baseline) in patients with RA. Secondary objectives included comparing the longer-term effect of CBT-I on sleep and RA-related outcomes at 26 weeks’ follow-up. Methods In a randomised controlled trial, using a parallel group design, the experimental intervention was six weeks’ CBT-I; the control comparator was usual care. CBT-I was delivered face-to-face by a CBT-I trained nurse. The primary analyses were based on the intention-to-treat (ITT) population; missing data were statistically handled using repeated-measures linear mixed effects models adjusted for the level at baseline. Results The ITT population consisted of 62 patients (89% women), with an average age of 58 years (SD 10), DAS28-CRP of 3.4 (SD 1.0), Insomnia Severity Index (ISI) score of 18.9 (SD 4.4) and median Patient Global Assessment score of 55 (IQR 28;71). When primary outcome was measured by PSG at week seven, sleep efficiency was 88.7% in the CBT-I group, compared to 83.7% in the control group (difference: 5.0 [95% CI -0.4 to 10.4]; p =0.068) (See Table 1). Secondary outcomes measured by PSG had not improved at week 26 either. However, for all secondary sleep and RA-related patient-reported outcomes, there were statistically highly significant differences between CBT-I and usual care e.g. insomnia (ISI: -9.8 [95% CI -11.8 to -7.9]), RA impact of disease (RAID: -1.4 [95% CI-1.9 to -0.80]) and Patient Global Assessment (-13.0 [95% CI -20.9 to -5.1]) at 26 weeks’ follow-up. Table 1. Primary and key secondary outcomes at week 7 and week 26, and differences between treatment groups (based on the ITT population) CBT-I n=31 Usual care n=31 Difference between groups (95% CI ) P-value At week 7 Sleep efficiency (PSG, %) 1 88.7 (1.8) 83.7 (2.0) 5.0 (-0.4 to 10.4) 0.068 At week 26 Sleep efficiency (PSG, %) 84.8 (1.9) 86.3 (2.0) -1.5 (-7.0 to 3.9) 0.577 Total sleep time (PSG, minutes) 376.5 (11.8) 394.6 (12.8) -18.1 (-52.5 to 16.4) 0.302 Sleep onset latency (PSG, minutes) 14.2 (2.2) 10.0 (2.4) 4.2 (-2.2 to 10.7) 0.197 Wake after sleep onset (PSG, minutes) 52.1 (10.7) 41.5 (11.6) 10.6 (-20.7 to 41.9) 0.505 Insomnia severity (ISI 0-28) 2 7.6 (0.7) 17.4 (0.7) -9.8 (-11.8 to -7.9) &lt;0.0001 Sleep quality global (PSQI 0-21) 3 5.9 (0.5) 11.1 (0.5) -5.2 (-6.6 to -3.8) &lt;0.0001 Fatigue (BRAF-MDQ 0-70) 4 24.0 (1.4) 36.4 (1.5) -12.4 (-16.5 to -8.4) &lt;0.0001 RA impact of disease (RAID 0-10) 5 4.2 (0.20) 5.5 (0.20) -1.4 (-1.9 to -0.80) &lt;0.0001 Depressive symptoms (HADS-D 0-21) 6 3.8 (0.5) 6.5 (0.5) -2.7 (-4.1 to -1.3) &lt;0.0001 Values are reported as least squares means (standard errors) by group, while the differences between groups are reported with 95% confidence intervals. 1 Polysomnography, 2 Insomnia Severity Index, 3 Pittsburgh Sleep Quality Index, 4 Bristol Rheumatoid Arthritis Fatigue - Multidimensional Questionnaire, 5 Rheumatoid Arthritis Impact of Disease, 6 Hospital Anxiety and Depression Scale - Depression. Conclusion Nurse-led, group-based CBT-I for two hours per week for six weeks, did not improve objectively measured sleep efficiency or any other outcomes measured by PSG. However, CBT-I showed long-term improvement on patient-reported outcomes such as fatigue, impact of disease, depression, pain, and Patient Global Assessment – a finding that could have important clinical implications. References [1]PMID: 25620673 [2]PMID: 16804151 [3]PMID: 26434673 Acknowledgements We thank the participants for their time and commitment and the patient research partners for valuable insight into the process and content of the trial. Disclosure of Interests None declared